由于操作人员未及时对1036-A190712阿糖胞苷粗品标识“待处理”

Because the operator did not label the "crude" cytarabine 1036-A190712 in time, the batch of cytarabine crude was still marked as "qualified". At the same time, during the investigation, it was found that the cytarabine A-1 intermediate in the batch of production records was reported as unqualified, but the batch of cytarabine A-1 intermediate reports had been retested, and the relevant personnel did not The qualified intermediate report form was included in the batch production record in time, and the product QA Yan Yong did not find this problem. <br><br><br>1. Place 1036-A190712 batches of crude products in the isolation area and mark "Pending", use drawstrings to enclose the isolation area and daily lock the intermediate storage room. On November 15, 2019, the material review and processing records were completed, waiting for EHS destruction; at the same time, the intermediate report form after the retest was included in the batch production records. Since this batch of crude products is waiting for EHS destruction, it will not continue production, so it has no impact on subsequent production. <br>2. The packaging form of crude cytarabine is: inner packaging double PE bag + outer packaging cardboard drum, which can effectively isolate the product from the external environment. At the same time, the batch of crude product is stored in a separate area of ​​the intermediate storage room, and other materials Certain physical isolation can avoid confusion, can also effectively avoid pollution and cross-contamination, and the risk can be controlled. <br>3. At the same time, check the batch records of the product QA Yan Yong's audit of the cytarabine intermediate OOS from 2017 to 2019 to see if the same situation exists. The results of the investigation are shown in the following table. No similar situation occurs and the risk is controllable. <br><br>CP-TZ-API-D-TZ-API-12CY-19002-20001: Mark 1036-A190712 crude cytarabine crude product "to be processed" and paste the label in the isolation area. <br>CP-TZ-API-D-TZ-API-12CY-19002-20002: Trace 1036-A190712 crude cytarabine crude to destruction. <br>CP-TZ-API-D-TZ-API-12CY-19002-20003: Training H0-SOP-60003 "Material Disposal and Destruction Management Procedures" for supervisor Xie Haibo and post operators, emphasizing that: the intermediate has exceeded the expiration date For products to be processed, the “Pending” logo should be pasted in time.<br>CP-TZ-API-D-TZ-API-12CY-19002-20004: Trained H0-SOP-01002 "GMP Original Records Management Procedures" for Xie Haibo, director of cytarabine production, and product QA Yan Yong, emphasizing: records Should be timely, QA personnel should confirm whether they meet the SOP requirements when reviewing the records.

Due to the operator's failure to identify 1036-A190712 a glycoside crude product in time as "to be processed", resulting in the batch of alyglycine crude is still identified as "qualified". At the same time in the course of investigation found that the batch of production records of aglycoside A-1 intermediates reported as unqualified, but the batch of aglycoside A-1 intermediates reported to have been retested qualified, and the relevant personnel did not timely qualified intermediates report single into the batch production records, product QA Yanyong also did not find the problem. <br><br>1. Place the 1036-A190712 batch of rough goods in the quarantine area and label "pending treatment", surround the isolation area with a pull rope and lock the intermediate sequester on a daily basis. On 2019.11.15, the material review and processing records will be completed pending destruction by EHS, and the retest intermediate report form will be included in the batch production records. As the batch is awaiting EHS destruction and production will not continue, it has no effect on subsequent production.<br>2. A glycoside crude packaging form is: the inner packaging double-layer PE bag and outer packaging cardboard bucket, can effectively isolate the product and the external environment, while the batch of crude goods stored in the intermediate staging between a separate area, with other materials have a certain physical isolation, can avoid confusion, but also effectively avoid pollution and cross-contamination, risk control.<br>3. At the same time, the product QA YanYong in 2017 to 2019 to review the batch records involving the aglycoside intermediate OOS to check to see if there is the same situation. The results are as follows, no one has the same situation, the risk can be controlled.<br><br>CP-TZ-API-D-TZ-API-12CY-19002-20001: Label "pending" for 1036-A190712 batches of aglycine crude and paste the logo in the quarantine area.<br>CP-TZ-API-D-TZ-API-12CY-19002-20002: Track 1036-A190712 batches of alyssalysin crude to destroy.<br>CP-TZ-API-D-TZ-API-12CY-19002-20003: Training of H0-SOP-60003 Material Disposal and Destruction Management Procedures for supervisor Xie Haibo and job operators, emphasizing that: The intermediate has exceeded the expiration date of the pending products, it is necessary to paste the "to be processed" logo in a timely manner.<br>CP-TZ-API-D-TZ-API-12CY-19002-20004: Training h0-SOP-01002 GMP Original Records Management Procedure for The Head of Aglycinin production, stressed that: Records should be timely and QA personnel should confirm compliance with OPS requirements when reviewing records.

Due to the operator's failure to mark 1036-a190712 crude arabinoside as "to be processed", this batch of crude arabinoside is still marked as "qualified". Meanwhile, during the investigation, it was found that the intermediate of cytarabine A-1 in the batch production record was unqualified, but the intermediate of cytarabine A-1 in the batch was retested to be qualified, and the qualified intermediate report was not included in the batch production record in time by relevant personnel, and the product QA Yan Yong did not find the problem.<br>1. Put 1036-a190712 batches of rough products in the isolation area and mark "to be processed". Use the pull rope to enclose the isolation area and lock the intermediate temporary storage room daily. On November 15, 2019, complete the material review and treatment record, wait for EHS destruction; at the same time, include the intermediate report after retest into the batch production record. As this batch of rough products is waiting for EHS destruction, production will not continue, so there is no impact on subsequent production.<br>2. The packaging form of cytarabine crude product is: Double PE bags with inner packaging and cardboard barrels with outer packaging, which can effectively isolate the product from the external environment. At the same time, the batch of crude product is stored in a separate area of the intermediate temporary storage room, which has a certain physical isolation with other materials, can avoid confusion, can effectively avoid pollution and cross pollution, and the risk is controllable.<br>3. At the same time, Yan Yong, QA of the product, checked the batch records of OOS involving cytarabine intermediates from 2017 to 2019 to see if they were the same. The troubleshooting results are shown in the table below. No similar situation occurs and the risk is controllable.<br>Cp-tz-api-d-tz-api-12cy-19002-20001: 1036-a190712 batches of crude cytarabine were identified as "to be processed", and the identification was pasted in the isolation area.<br>Cp-tz-api-d-tz-api-12cy-19002-20002: trace and destroy 1036-a190712 batches of crude cytarabine.<br>Cp-tz-api-d-tz-api-12cy-19002-20003: to train Xie Haibo in charge and the post operators on h0-sop-60003 material disposal and destruction management procedure, emphasizing that for the products to be processed whose intermediates have exceeded the validity period, the "to be processed" mark should be pasted in time.<br>Cp-tz-api-d-tz-api-12cy-19002-20004: Xie Haibo, the production director of cytarabine, and Yan Yong, the product QA, were trained in h0-sop-01002 GMP original record management procedure. It was emphasized that records should be timely and QA personnel should confirm whether they meet the requirements of SOP when reviewing records.<br>